FDA's New Vaping Policy Blindsided Regulators, Staffers Say

Senior officials at the U.S. Food and Drug Administration's tobacco center were reportedly blindsided by a recent decision to allow more unauthorized electronic cigarettes and nicotine pouches onto the market. The guidelines, posted online before former FDA Commissioner Marty Makary resigned, will permit companies to launch certain nicotine-based products before they have been fully vetted by regulators. According to two staffers speaking on condition of anonymity, officials tasked with enforcing vaping regulations were not consulted on the changes and only learned of them the night before publication. This sudden policy shift has sparked internal confusion regarding its origins and authorization. The memo breaks with longstanding FDA policy requiring scientific verification of health benefits for smokers before new products are introduced. The agency has convened meetings to grapple with implementing the six-page guidance, which bypasses the federally required period for public comment. Critics, including former FDA tobacco director Mitch Zeller, have questioned whether the true subject matter experts opposed the policy and were ordered to proceed regardless. The new approach is intended to strengthen protections against youth nicotine addiction while supporting evidence-based alternatives for adult smokers. However, the policy may have little impact on the flavors already widely available in the U.S. market, as unauthorized vapes containing various flavors have been flooding the market for years. The guidance suggests that only e-cigarettes under "scientific review" will qualify to launch without FDA authorization, which experts believe will primarily benefit larger tobacco companies with the resources to navigate the review process. Smaller companies fear being left behind in this shifting regulatory landscape.

(Source：Latestly)